Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. Papi, A., Chipps, B. E., Beasley, R., Panettieri, R. A., Israel, E., Cooper, M., Dunsire, L., Jeynes-Ellis, A., Johnsson, E., Rees, R., Cappelletti, C., & Albers, F. C. The New England Journal of Medicine, 386(22):2071–2083, June, 2022.
doi  abstract   bibtex   
BACKGROUND: As asthma symptoms worsen, patients typically rely on short-acting β2-agonist (SABA) rescue therapy, but SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations. The use of a fixed-dose combination of albuterol and budesonide, as compared with albuterol alone, as rescue medication might reduce the risk of severe asthma exacerbation. METHODS: We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial. Adults and adolescents (≥12 years of age) were randomly assigned in a 1:1:1 ratio to one of three trial groups: a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide (with each dose consisting of two actuations of 90 μg and 80 μg, respectively [the higher-dose combination group]), a fixed-dose combination of 180 μg of albuterol and 80 μg of budesonide (with each dose consisting of two actuations of 90 μg and 40 μg, respectively [the lower-dose combination group]), or 180 μg of albuterol (with each dose consisting of two actuations of 90 μg [the albuterol-alone group]). Children 4 to 11 years of age were randomly assigned to only the lower-dose combination group or the albuterol-alone group. The primary efficacy end point was the first event of severe asthma exacerbation in a time-to-event analysis, which was performed in the intention-to-treat population. RESULTS: A total of 3132 patients underwent randomization, among whom 97% were 12 years of age or older. The risk of severe asthma exacerbation was significantly lower, by 26%, in the higher-dose combination group than in the albuterol-alone group (hazard ratio, 0.74; 95% confidence interval [CI], 0.62 to 0.89; P = 0.001). The hazard ratio in the lower-dose combination group, as compared with the albuterol-alone group, was 0.84 (95% CI, 0.71 to 1.00; P = 0.052). The incidence of adverse events was similar in the three trial groups. CONCLUSIONS: The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies. (Funded by Avillion; MANDALA ClinicalTrials.gov number, NCT03769090.).
@article{papi_albuterol-budesonide_2022,
	title = {Albuterol-{Budesonide} {Fixed}-{Dose} {Combination} {Rescue} {Inhaler} for {Asthma}},
	volume = {386},
	issn = {1533-4406},
	doi = {10.1056/NEJMoa2203163},
	abstract = {BACKGROUND: As asthma symptoms worsen, patients typically rely on short-acting β2-agonist (SABA) rescue therapy, but SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations. The use of a fixed-dose combination of albuterol and budesonide, as compared with albuterol alone, as rescue medication might reduce the risk of severe asthma exacerbation.
METHODS: We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial. Adults and adolescents (≥12 years of age) were randomly assigned in a 1:1:1 ratio to one of three trial groups: a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide (with each dose consisting of two actuations of 90 μg and 80 μg, respectively [the higher-dose combination group]), a fixed-dose combination of 180 μg of albuterol and 80 μg of budesonide (with each dose consisting of two actuations of 90 μg and 40 μg, respectively [the lower-dose combination group]), or 180 μg of albuterol (with each dose consisting of two actuations of 90 μg [the albuterol-alone group]). Children 4 to 11 years of age were randomly assigned to only the lower-dose combination group or the albuterol-alone group. The primary efficacy end point was the first event of severe asthma exacerbation in a time-to-event analysis, which was performed in the intention-to-treat population.
RESULTS: A total of 3132 patients underwent randomization, among whom 97\% were 12 years of age or older. The risk of severe asthma exacerbation was significantly lower, by 26\%, in the higher-dose combination group than in the albuterol-alone group (hazard ratio, 0.74; 95\% confidence interval [CI], 0.62 to 0.89; P = 0.001). The hazard ratio in the lower-dose combination group, as compared with the albuterol-alone group, was 0.84 (95\% CI, 0.71 to 1.00; P = 0.052). The incidence of adverse events was similar in the three trial groups.
CONCLUSIONS: The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies. (Funded by Avillion; MANDALA ClinicalTrials.gov number, NCT03769090.).},
	language = {eng},
	number = {22},
	journal = {The New England Journal of Medicine},
	author = {Papi, Alberto and Chipps, Bradley E. and Beasley, Richard and Panettieri, Reynold A. and Israel, Elliot and Cooper, Mark and Dunsire, Lynn and Jeynes-Ellis, Allison and Johnsson, Eva and Rees, Robert and Cappelletti, Christy and Albers, Frank C.},
	month = jun,
	year = {2022},
	pmid = {35569035},
	keywords = {Administration, Inhalation, Adolescent, Adult, Albuterol, Asthma, Budesonide, Child, Child, Preschool, Double-Blind Method, Drug Combinations, Ethanolamines, Formoterol Fumarate, Glucocorticoids, Humans, Maintenance Chemotherapy, Nebulizers and Vaporizers, Symptom Flare Up, Young Adult},
	pages = {2071--2083},
}
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